FDA Announces New Peanut Allergy Health Claim

Read Neal Fortin's summary of the new guidance, and link to supporting documents.

Peanuts in peanut shell.

The U.S. Food and Drug Administration (FDA) announced new health claims related to the introduction of allergenic foods to infants and the reduction in the risk of developing food allergies. Beginning December 8, 2021, manufacturers may use the following claims on the label of any food product that qualifies for the claims:

“If a baby has severe eczema, egg allergy or both, introducing age-appropriate, peanut-containing foods as early as 4 months may reduce the risk of developing a peanut allergy. Caregivers should check with the baby’s healthcare provider before feeding the baby peanut-containing foods.”

or

“For babies with an increased risk of peanut allergy (babies with severe eczema, egg allergy or both), introducing age-appropriate, peanut-containing foods as early as 4 months may reduce the risk of developing a peanut allergy. Caregivers should check with the baby’s healthcare provider before feeding the baby peanut-containing foods.”

These are Food and Drug Administration Modernization Act (FDAMA) health claims. Under the FDAMA, a manufacturer may submit to FDA a notification for a health claim based on an authoritative statement from a scientific body of the US Government or the National Academy of Sciences. In this case, the authoritative statement came from the Dietary Guidelines for Americans 2020–2025.

These claims are in addition to the qualified health claim that the agency allowed in 2017 regarding early peanut introduction and reduced risk of developing a peanut allergy.

Peanut allergy is one of the most common food allergies. The National Institute of Allergy and Infectious Diseases has developed recommendations to prevent the development of peanut allergy.

Companies are permitted to start using the approved claims on December 8, 2021. These claims are in addition to a qualified health claim that the FDA acknowledged in 2017, which was also related to the link between early peanut introduction and the reduced risk of developing peanut allergies.

Learn more about health claims Neal Fortin's courses on United States and International Food Laws and Regulations. Enrollment is fast and easy through MSU Lifelong Education. MSU’s Lifelong Education Program requires no application fee, no college transcripts, and no entrance exam.

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